Open-Angle GlaucomaPhase 1/2NCT01157364
Safety and Efficacy of a New Ophthalmic Formulation of Bimatoprost in Patients With Open Angle Glaucoma and Ocular Hypertension
A Phase 1/2 study testing bimatoprost 20 µg generation 2, bimatoprost 15 µg generation 2 and bimatoprost 10 µg generation 2 in people with Open-Angle Glaucoma and Ocular Hypertension, run by Allergan at 57 sites in 10 countries.
Trial summary
This study will evaluate the safety and efficacy of new ophthalmic formulations of bimatoprost in patients with open angle glaucoma and ocular hypertension. At least 3 dose strengths will be evaluated based on internal data review of each cohort. The study was planned to be conducted in 2 stages. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open-Angle Glaucoma, Ocular Hypertension
- What is being tested?
- bimatoprost 20 µg generation 2, bimatoprost 15 µg generation 2 and bimatoprost 10 µg generation 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 57 sitesin 10 countries
- Study dates
- 23 Sep 2010to 9 Aug 2016
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of open angle glaucoma or ocular hypertension
Who cannot join
- Uncontrolled medical conditions
- Anticipated wearing of contact lenses during the study
Trial locations and contacts
57 sites in 10 countries.
57 sites in 10 countries
United States36 sites
Sall Research Medical Center
Artesia, California, 90701
Emory University, The Emory Eye Center
Atlanta, Georgia, 30322
Keystone Research LTD
Austin, Texas, 78731
Glaucoma Consultants
Baltimore, Maryland, 21204
Tufts Medical Center/New England Eye Center
Boston, Massachusetts, 02111
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
The Eye Associates of Manatee
Bradenton, Florida, 34209
Charlotte Eye Ear Nose & Throat Associates, PA
Charlotte, North Carolina, 28210
Scott & Christie and Associates
Cranberry Township, Pennsylvania, 16066
Glaucoma Associates of TX
Dallas, Texas, 75231
Cornerstone Eye Care
High Point, North Carolina, 27262
Moyes Eye Center
Kansas City, Missouri, 64154
Shiley Eye Center, Hamilton Glaucoma Center, University of California, San Diego
La Jolla, California, 92093
Doheny Eye Institute
Los Angeles, California, 90033
Ophthalmic Consultants of Long Island
Lynbrook, New York, 11563
ActivMed Practices & Research
Methuen, Massachusetts, 01844
Glaucoma Associates of NY
New York, New York, 10003
Specialty Eye Care
Parker, Colorado, 80134
Philadelphia Eye Associates
Philadelphia, Pennsylvania, 19148
Legacy Good Samaritan - Devers Eye Institute
Portland, Oregon, 97210
Martel Eye Medical Group
Rancho Cordova, California, 95670
Shasta Eye Medical Group, Inc.
Redding, California, 96002
Rochester Ophthalmological Group PC
Rochester, New York, 14618
Coastal Research Associates
Roswell, Georgia, 30076
Grutzmacher and Lewis, Inc.
Sacramento, California, 95815
Focus Clinical Research
Salt Lake City, Utah, 84107
R and R Eye Research
San Antonio, Texas, 78229
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240
Pacific Eye Surgeons
San Luis Obispo, California, 93401
Northern New Jersey Eye Institute PA
South Orange, New Jersey, 07079
Spokane Eye Clinical Research
Spokane, Washington, 99204
Springfield Clinic
Springfield, Illinois, 62703
Wolstan & Goldberg Eye Associates
Torrance, California, 90505
Wenatchee Valley Medical Center
Wenatchee, Washington, 98801
Clinical Eye Research of Boston/ Charles River Eye Associates
Winchester, Massachusetts, 01890
James D. Branch, MD
Winston-Salem, North Carolina, 27101
Canada7 sites
Institut de l'œil des Laurentides
Boisbriand, Quebec, J7H 1S6
A.C. S. Crichton Prof. Corp
Calgary, Alberta, T3E-7M8
Anjema Eye Institute
Chatham, Ontario, N7M 5J7
Eye Care Center
Halifax, Nova Scotia, B3H 2Y9
Galen Eye Centre
Kingston, Ontario, K7K 6Z6
Ivey Eye Institute
London, Ontario, N6A 4V2
Clarity Eye Institute
Vaughan, L4K 0C5
Israel3 sites
Kaplan Medical Center
Rohovot, 76100
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
The Sam Rothberg Glaucoma Center,
Tel HaShomer, 52621
Philippines3 sites
Asian Eye Institute
Makati City, 1200
Pacific Eye and Laser Institute (PELI)
Makati City, 1209
St. Lukes Medical Center-Quezon City
Metro Manila, Quezon City 1112
Australia2 sites
Melbourne Eye Specialists
Fitzroy, 3065
Eye Associates
Sydney New South Wales, 2000
Spain2 sites
Valles Oftalmologia Recerca, Hospital General de Catalunya,
Sant Cugat del Vallès, 08195
Fundacion Oftalmologica Del Mediterraneo
Valencia, 46015
Brazil1 site
Universidade Federal de São Paulo/Escola Paulista de Medicina/Hospital São Paulo Departamento de Oftalmologia
São Paulo, 04023-062
Germany1 site
Staedtisches Klinikum Department of Opthalmology
Karlsruhe, 76133
About this study
Official title: An Open-label (Stage 1) and Randomized (Stage 2), 24 Month Study of Safety and Efficacy of Bimatoprost Drug Delivery System in Patients With Open-Angle Glaucoma or Ocular Hypertension
This study will evaluate the safety and efficacy of new ophthalmic formulations of bimatoprost in patients with open angle glaucoma and ocular hypertension. At least 3 dose strengths will be evaluated based on internal data review of each cohort. The study was planned to be conducted in 2 stages. Stage 1 was an open-label and Stage 2 was planned to be masked; however only Stage 1 was conducted.
- Conditions
- Open-Angle Glaucoma, Ocular Hypertension
- Being tested
- bimatoprost 20 µg generation 2, bimatoprost 15 µg generation 2, bimatoprost 10 µg generation 2, bimatoprost 6 µg generation 2, bimatoprost 15 µg generation 1
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bimatoprost 20 µg generation 2Drug
Single dose of bimatoprost ophthalmic administered in the study eye on Day 1.
bimatoprost 15 µg generation 2Drug
Single dose of bimatoprost ophthalmic administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).
bimatoprost 10 µg generation 2Drug
Single dose of bimatoprost ophthalmic 10 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).
bimatoprost 6 µg generation 2Drug
Single dose of bimatoprost ophthalmic 6 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).
bimatoprost 15 µg generation 1Drug
Single dose of bimatoprost ophthalmic 15 µg generation 1 administered in the study eye on Day 1.
bimatoprost 10 µg generation 1Drug
Single dose of bimatoprost ophthalmic 10 µg generation 1 administered in the study eye on Day 1.
bimatoprost 0.03%Drug
Also called LUMIGAN®
One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
| Study group | Role | What they receive |
|---|---|---|
| bimatoprost 20 µg generation 2, bimatoprost 0.03% | Other | Single dose of bimatoprost ophthalmic 20 µg generation 2 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. Receives: Drug: bimatoprost 20 µg generation 2; Drug: bimatoprost 0.03% |
| bimatoprost 15 µg generation 2, bimatoprost 0.03% | Other | Single dose of bimatoprost ophthalmic 15 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. Receives: Drug: bimatoprost 15 µg generation 2; Drug: bimatoprost 0.03% |
| bimatoprost 10 µg generation 2, bimatoprost 0.03% | Other | Single dose of bimatoprost ophthalmic 10 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. Receives: Drug: bimatoprost 10 µg generation 2; Drug: bimatoprost 0.03% |
| bimatoprost 6 µg generation 2, bimatoprost 0.03% | Other | Single dose of bimatoprost ophthalmic 6 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. Receives: Drug: bimatoprost 6 µg generation 2; Drug: bimatoprost 0.03% |
| bimatoprost 15 µg generation 1, bimatoprost 0.03% | Other | Single dose of bimatoprost ophthalmic 15 µg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. Receives: Drug: bimatoprost 15 µg generation 1; Drug: bimatoprost 0.03% |
| bimatoprost 10 µg generation 1, bimatoprost 0.03% | Other | Single dose of bimatoprost ophthalmic 10 µg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. Receives: Drug: bimatoprost 10 µg generation 1; Drug: bimatoprost 0.03% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye
IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Measured: Baseline, Month 24
Secondary outcomes (3)
Time-Matched Intraocular Pressure (IOP) in the Study Eye
IOP is a measurement of the fluid pressure inside the study eye.
Measured: Baseline to Month 6
Mean Diurnal IOP in the Study Eye
IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0, 2, 4, 6, and 8 and averaged to determine the mean diurnal IOP.
Measured: Baseline, Month 6
Time to Rescue Treatment or Re-Treatment in the Study Eye
Time to rescue treatment or the second treatment in the generation 2 groups is defined as the time between the first treatment and the second treatment in the study eye.
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2010 (estimated)
- Study start23 Sep 2010
- Primary completion27 Jul 2016
- Study completion9 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Open-Angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01157364
- Sponsor's protocol ID
- 192024-041D
- Other IDs
- 2011-005091-42
- Status last verified
- Mar 2020
- First submitted
- 2 Jul 2010
- Last updated
- 30 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Craven ER, Walters T, Christie WC, Day DG, Lewis RA, Goodkin ML, Chen M, Wangsadipura V, Robinson MR, Bejanian M; Bimatoprost SR Study Group. 24-Month Phase I/II Clinical Trial of Bimatoprost Sustained-Release Implant (Bimatoprost SR) in Glaucoma Patients. Drugs. 2020 Feb;80(2):167-179. doi: 10.1007/s40265-019-01248-0.
PubMed 31884564Medeiros FA, Sheybani A, Shah MM, Rivas M, Bai Z, Werts E, Ahmed IIK, Craven ER. Single Administration of Intracameral Bimatoprost Implant 10 microg in Patients with Open-Angle Glaucoma or Ocular Hypertension. Ophthalmol Ther. 2022 Aug;11(4):1517-1537. doi: 10.1007/s40123-022-00527-6. Epub 2022 May 28.
PubMed 35643967
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label (Stage 1) and Randomized (Stage 2), 24 Month Study of Safety and Efficacy of Bimatoprost Drug Delivery System in Patients With Open-Angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT01157364
- Acronym / sponsor ID
- 192024-041D
- Conditions
- Open-Angle Glaucoma, Ocular Hypertension
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2010 (actual)
- Primary completion
- 27 Jul 2016 (actual)
- Study completion
- 9 Aug 2016 (actual)
- First posted
- 7 Jul 2010 (estimated)
- Results
- Posted 30 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and efficacy of new ophthalmic formulations of bimatoprost in patients with open angle glaucoma and ocular hypertension. At least 3 dose strengths will be evaluated based on internal data review of each cohort. The study was planned to be conducted in 2 stages. Stage 1 was an open-label and Stage 2 was planned to be masked; however only Stage 1 was conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| bimatoprost 20 µg generation 2, bimatoprost 0.03% | Other | Drug: bimatoprost 20 µg generation 2, Drug: bimatoprost 0.03%Single dose of bimatoprost ophthalmic 20 µg generation 2 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. |
| bimatoprost 15 µg generation 2, bimatoprost 0.03% | Other | Drug: bimatoprost 15 µg generation 2, Drug: bimatoprost 0.03%Single dose of bimatoprost ophthalmic 15 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. |
| bimatoprost 10 µg generation 2, bimatoprost 0.03% | Other | Drug: bimatoprost 10 µg generation 2, Drug: bimatoprost 0.03%Single dose of bimatoprost ophthalmic 10 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. |
| bimatoprost 6 µg generation 2, bimatoprost 0.03% | Other | Drug: bimatoprost 6 µg generation 2, Drug: bimatoprost 0.03%Single dose of bimatoprost ophthalmic 6 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. |
| bimatoprost 15 µg generation 1, bimatoprost 0.03% | Other | Drug: bimatoprost 15 µg generation 1, Drug: bimatoprost 0.03%Single dose of bimatoprost ophthalmic 15 µg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. |
| bimatoprost 10 µg generation 1, bimatoprost 0.03% | Other | Drug: bimatoprost 10 µg generation 1, Drug: bimatoprost 0.03%Single dose of bimatoprost ophthalmic 10 µg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of open angle glaucoma or ocular hypertension
Key exclusion criteria (2 listed)
- Uncontrolled medical conditions
- Anticipated wearing of contact lenses during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bimatoprost 20 µg generation 2Single dose of bimatoprost ophthalmic administered in the study eye on Day 1. | Drug | bimatoprost 20 µg generation 2, bimatoprost 0.03% |
| bimatoprost 15 µg generation 2Single dose of bimatoprost ophthalmic administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). | Drug | bimatoprost 15 µg generation 2, bimatoprost 0.03% |
| bimatoprost 10 µg generation 2Single dose of bimatoprost ophthalmic 10 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). | Drug | bimatoprost 10 µg generation 2, bimatoprost 0.03% |
| bimatoprost 6 µg generation 2Single dose of bimatoprost ophthalmic 6 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). | Drug | bimatoprost 6 µg generation 2, bimatoprost 0.03% |
| bimatoprost 15 µg generation 1Single dose of bimatoprost ophthalmic 15 µg generation 1 administered in the study eye on Day 1. | Drug | bimatoprost 15 µg generation 1, bimatoprost 0.03% |
| bimatoprost 10 µg generation 1Single dose of bimatoprost ophthalmic 10 µg generation 1 administered in the study eye on Day 1. | Drug | bimatoprost 10 µg generation 1, bimatoprost 0.03% |
| bimatoprost 0.03%Also: LUMIGAN®One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months. | Drug | bimatoprost 10 µg generation 1, bimatoprost 0.03%, bimatoprost 10 µg generation 2, bimatoprost 0.03%, bimatoprost 15 µg generation 1, bimatoprost 0.03%, bimatoprost 15 µg generation 2, bimatoprost 0.03%, bimatoprost 20 µg generation 2, bimatoprost 0.03%, bimatoprost 6 µg generation 2, bimatoprost 0.03% |
Primary outcome
Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye
Time frame: Baseline, Month 24
IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
3 secondary outcomes
Time-Matched Intraocular Pressure (IOP) in the Study Eye
Time frame: Baseline to Month 6
Mean Diurnal IOP in the Study Eye
Time frame: Baseline, Month 6
Time to Rescue Treatment or Re-Treatment in the Study Eye
Time frame: 24 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31884564Craven ER, Walters T, Christie WC, Day DG, Lewis RA, Goodkin ML, Chen M, Wangsadipura V, Robinson MR, Bejanian M; Bimatoprost SR Study Group. 24-Month Phase I/II Clinical Trial of Bimatoprost Sustained-Release Implant (Bimatoprost SR) in Glaucoma Patients. Drugs. 2020 Feb;80(2):167-179. doi: 10.1007/s40265-019-01248-0.
- Derived from this study: PubMed 35643967Medeiros FA, Sheybani A, Shah MM, Rivas M, Bai Z, Werts E, Ahmed IIK, Craven ER. Single Administration of Intracameral Bimatoprost Implant 10 microg in Patients with Open-Angle Glaucoma or Ocular Hypertension. Ophthalmol Ther. 2022 Aug;11(4):1517-1537. doi: 10.1007/s40123-022-00527-6. Epub 2022 May 28.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Allergan
57 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing bimatoprost 20 µg generation 2, bimatoprost 15 µg generation 2 and bimatoprost 10 µg generation 2 in people with Open-Angle Glaucoma and Ocular Hypertension, run by Allergan at 57 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in United States, Canada, Israel, Philippines, Australia and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye (time frame: Baseline, Month 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01157364, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2020.